GI Medical Cannabis Study on IBD

NCT03886532 | Withdrawn DMC FDA Drug

• 1 other identifier: 18-015221
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

Create a registry that will described the natural history and landscape of medical cannabis product use in patients with chronic abdominal pain or inflammatory bowel disease. Quantitatively describe the pharmacokinetic (PK) profile of select medical cannabis products in patients with chronic neuropathic (abdominal) pain or inflammatory bowel disease. To create an educational program for families that have participated in the research for those families who opt for this component. Although these are not research in nature, they are a direct result of the proposed research and are included in the protocol to demonstrate the study's deliverables.

Conditions

Inflammatory Bowel Diseases; Neuropathic Pain

Outcome Measures

Primary Outcomes (1)

• Change in symptoms

  Relief of primary indication (perceived therapeutic benefit of product) reported via parent or caregiver on a 1-10 Lichert scale with 1 being minimally effective and 10 being extremely effective.

  1 year

Secondary Outcomes (2)

• Patient or caregiver reported side effects

  1 year

• Changes in drug concentrations

  1 year

Study Arms (2)

Medical Marijuana

Those subject taking only medical marijuana as standard of care. Will collect registry data and collect blood samples.

Other: Medical Marijuana

CBD only products

Those subjects taking only CBD products as standard of care. Will collect registry data and collect blood samples.

Other: Medical Marijuana

Interventions

Medical Marijuana OTHER

registry and blood samples

CBD only products; Medical Marijuana

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who are diagnosed with inflammatory bowel disease (IBD) and are taking medical marijuana or cannabidiol (CBD) legally

You may qualify if:

• Individuals who consume cannabis products in a state which has legalized medical cannabis for the treatment of inflammatory bowel disease and chronic neuropathic (abdominal) pain.
• Individuals who have a diagnosis of Inflammatory Bowel Disease or chronic neuropathic (abdominal) pain.

You may not qualify if:

• Consumption of cannabis products that are not obtained from a state-sanctioned dispensary.
• Non English speaking individuals.

Sponsors & Collaborators

• Children's Hospital of Philadelphia: lead

Biospecimen

Retention: SAMPLES WITHOUT DNA

We will consent subjects to retain microsampling samples.

MeSH Terms

Conditions

Inflammatory Bowel Diseases; Neuralgia

Interventions

Medical Marijuana

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pharmaceutical Preparations

Study Officials

• Athena F Zuppa, MD MSCE

  Children's Hospital of Philadelphia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 14, 2019
• First Posted: March 22, 2019
• Study Start: November 1, 2019
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2020
• Last Updated: September 27, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share